reltone 200 mg (80056-143)

Drug Facts

Product Profile

Brand Name reltone 200 mg

Generic Name ursodiol

Labeler intra-sana laboratories

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

ursodiol 200 mg/1

Manufacturer

Intra-Sana Laboratories

Identifiers & Regulatory

Product NDC 80056-143

Product ID 80056-143_1fc18c67-20db-4fe5-bc22-2772f0788d13

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205789

Listing Expiration 2026-12-31

Marketing Start 2020-07-01

Pharmacologic Class

Established (EPC)

bile acid [epc]

Chemical Structure

bile acids and salts [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80056143

Hyphenated Format 80056-143

Supplemental Identifiers

RxCUI

412174 2376942 2477896 2477898

UPC

0380056144010 0380056143013

UNII

724L30Y2QR

NUI

N0000175802 M0002475

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name reltone 200 mg (source: ndc)

Generic Name ursodiol (source: ndc)

Application Number ANDA205789 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1

source: ndc

Packaging

100 CAPSULE in 1 BOTTLE (80056-143-01)

source: ndc

Packages (1)

80056-143-01 100 CAPSULE in 1 BOTTLE (80056-143-01)

Ingredients (1)

ursodiol (200 mg/1)

Linked Drug Pages (1)

Reltone 200 mg, Reltone 400 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1fc18c67-20db-4fe5-bc22-2772f0788d13", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0380056144010", "0380056143013"], "unii": ["724L30Y2QR"], "rxcui": ["412174", "2376942", "2477896", "2477898"], "spl_set_id": ["d1c28b0b-8f3c-4d60-8182-24a4c659d762"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Intra-Sana Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (80056-143-01)", "package_ndc": "80056-143-01", "marketing_start_date": "20210215"}], "brand_name": "Reltone 200 mg", "product_id": "80056-143_1fc18c67-20db-4fe5-bc22-2772f0788d13", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "80056-143", "generic_name": "Ursodiol", "labeler_name": "Intra-Sana Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Reltone 200 mg", "active_ingredients": [{"name": "URSODIOL", "strength": "200 mg/1"}], "application_number": "ANDA205789", "marketing_category": "ANDA", "marketing_start_date": "20200701", "listing_expiration_date": "20261231"}